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Study on the Soft Capsules of the Effective Fractions from "Antipyretic Analgesics Powder"

Author: LiYaBing
Tutor: ZhouBenJie
School: Southern Medical University,
Course: Pharmacy
Keywords: The fever pain relief scattered Active site Inclusion technique Soft Capsule Quality standards Stability
CLC: R285
Type: Master's thesis
Year: 2011
Downloads: 54
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Abstract

Research background antipyretic analgesic the scattered old Chinese Professor Zang Kun Church, in the name of the experience side, after years of clinical validation, upper respiratory tract infection caused by exogenous cold fever, headache and sickness, have a significant effect. But because the party in the form of a powder used in clinical, patient dose, poor taste, taking very inconvenient to carry, both from the point of view of hygiene is not an aggregate specification. Therefore consider the introduction of modern extraction and separation technology, extraction separation of its administration site to the secondary development for tracking indicators of efficacy. The antipyretic analgesics powder by Bupleurum, Notopterygium, bacteria Chen, Gui herbs, use of supercritical C02 extraction and molecular distillation technology in the pre-extraction and separation work, classic antipyretic analgesic efficacy for tracking indicators using orthogonal test method to filter out of its anti-inflammatory active site. This active site Appearance brown yellow oil, to determine the initial multiple fat-soluble composition containing volatile oil. GC / MS analysis, the active site is mainly composed of cinnamic aldehyde and the acetyl phenetidine (phenacetin). In the the screened active site on the basis of, the research group followed its related efficacy and safety system evaluation to explore the feasibility of the development and utilization of, and carried out a preliminary study of its possible mechanism. The results show that the The antipyretic analgesic screened bulk active site, with good antipyretic analgesic efficacy, and the active site of good safety and low toxicity. The above studies indicate that the active site has good prospects for development. The purpose of this study is to the antipyretic analgesics powder active site development and utilization value has been recognized on the basis of its formulation research and development, including the dosage form, the preparation process of screening, formulation stability studies and quality standards research to the development of a safe, effective, quality control and stable new Chinese medicine. Taking into account the volatile oil having volatile lipophilic than that of air, light, heat sensitive, and therefore made of soft capsules, in order to improve the stability of the formulation. Research purposes is based on the antipyretic analgesics bulk active site of the completion of the preliminary studies for the purpose of the research projects are as follows: 1, antipyretic analgesic bulk active site quality control; 2 soft capsules, the active site of antipyretic analgesics powder preparations development; study the establishment of the antipyretic analgesics powder soft capsule formulation of the active site quality control standards; 4, antipyretic analgesics powder soft capsule formulation of the active site stability to inspect. Quality control research methods and results, fever and pain bulk active site of the active site of the chemical composition analysis by gas - mass spectrometry method. The active site Guizhi and Notopterygium of medicinal materials using thin-layer chromatography, combined with high performance liquid chromatography gradient elution fingerprint the qualitative identification of the active site. Establish a high performance liquid chromatography cinnamic aldehyde content of quantitative methods in the active site, and its methodological study, the results show that this method precision and good reproducibility, high recovery rate, cinnamic aldehyde content of 6.521% . 2, antipyretic analgesic bulk active site of soft capsule preparation of the laboratory preparation of soft capsules rubber and intracapsular, the rubber was immersed in the intracapsular mimetic soft capsules, and stored at room temperature and 40 ° C environment, and # 0,3,10 20 days remove the determination of the disintegration of the rubber. The prescription group (the intracapsular material for peanut oil), prescription (capsule material is a mixture of peanut oil and the active site) Comparison and analysis of variance. The results showed that there was significant difference (P = 0.000, F = 27.771) the rubber disintegration time between the groups of the type of prescription; another the prescription group 3 (intracapsular was active site) appears without disintegration phenomenon, seen from the visual data The disintegration of rubber is immersed in the peanut oil control, rubber immersed in the active site, the phenomenon appears to extend the disintegration time in the active site with a mixture of peanut oil. Delayed Dissolution rubber for the analog soft capsules experiment, this experiment made of inclusion complexes of the active site of the parcel in cyclodextrin, and then the preparation of soft capsules. Use of orthogonal design method, the antipyretic analgesics powder active site beta - cyclodextrin inclusion preferred to compare the different methods of inclusion rate yield. The inclusion process results show that the saturated aqueous solution method, the effect of various factors on the beta-CD in the inclusion had no significant effect (P = 0.125, F = 7.023: P = 0.460, F = 1.173: P = 0.501, F = 0.995 ). The best inclusion process conditions A2: B3: C1, stirring temperature of 40 ℃, stirring time was 2h, the active site with p-CD ratio of 1:8 (g / g). Ultrasonic, ultrasonic time A factor of significant difference (P = 0.013, F = 73.402), factor B of the amount of water and the active site of the proportion of C factors significant sexual affect (P 0.125, F = 7.023: P = 0.220, F = 3.539). Choose the best inclusion process conditions for A1: B1: C2, ultrasound time 2h, water addition of beta-CD amount of 15 times the active site with beta-CD ratio of 1:6 (g / g). Grinding method, the proportion of the active site of factor A and grinding time B factors have significant difference (P = 0.006, F = 166.032; P = 0.033, F = 29.555), the amount of water C factors no significant effect (P 0.157, F = 5.387). Choose the best lapping process conditions for A2: B2: C1, i.e. the grinding time of 2h, add water for beta-CD amount four times the active site with beta cyclodextrin (beta-CD) ratio of 1:8 (g / g). Select a saturated aqueous solution of Preparation clathrate again soft capsules pre-experiment, laboratory preparation of soft capsules rubber and intracapsular was immersed rubber sac mimetic soft capsules, and stored at room temperature and 40 ° C environment, and in the 0th , 3, 10, 20 days remove the determination of the disintegration of the rubber. The prescription group (the intracapsular material for peanut oil), the prescription group 2 (intracapsular matter for peanut oil and inclusion complex mixture) comparison and analysis of variance, the results show that the prescription capsule material containing the active site group rubber disintegration time comparison prescription group, no significant difference (P = 0.092, F = 3.016). Visible to the active site with a beta-cyclodextrin, can effectively improve the problem of the disintegration of the rubber, avoid the between intracapsular matter and rubber crosslinking reaction, thereby increasing the stability of the soft capsule. In the the soft capsules capsule prescription of screening studies, matrix type and amount, the amount of the wetting agent soybean lecithin study, a capsule was the best prescription: soybean Shantou and active site inclusion ratio of 1.5:1 , 1% soybean lecithin mixed research uniform, that is, too. 3, antipyretic analgesic bulk active site of soft capsule preparation quality standards the quality of the preparations Standards soft capsule of the active site Guizhi and Notopterygium of herbs ingredients using thin-layer chromatography, combined with high performance liquid chromatography gradient elution the fingerprint preparations qualitative identification. HPLC determination of the content of cinnamic aldehyde in the active site, the development of a more perfect quality standards. , Antipyretic analgesic bulk active site of soft capsule preparation Stability Stability of the preparation, sample observation room temperature and accelerated test program according to the quality standards were observed, soft the antipyretic analgesics powder active site Capsule formulation stability. Conclusion antipyretic analgesic bulk active site as oily substances, and has a certain odor and volatile, soft capsules with a high content of active ingredient compared with other solid dosage forms, bioavailability, rapid absorption, good stability, can effectively cover up the traditional Chinese medicine volatile bad smell, etc. of the ingredients, so soft capsules as an antipyretic analgesics powder preparation and development of the active site of the dosage form as is reasonably practicable. Rubber-disintegrating slow phenomenon, presumably due to the contact of the active site and soft capsules rubber cinnamic aldehyde component and rubber in the active site due to the crosslinking reaction occurs, Therefore, inclusion technique wrapped in the active site in the beta-cyclodextrin prepared soft gelatin capsules. The inclusion process results show that the ideal grinding method preferred inclusion process, the inclusion rate, high yield; saturated aqueous solution method preferred inclusion process after grinding method, and the process is more suitable for actual production, the final choice of a saturated aqueous solution as an antipyretic analgesic bulk active site of beta cyclodextrin inclusion. Pre-test again after inclusion complex soft capsules, the antipyretic analgesics powder active site after beta cyclodextrin inclusion overcome rubber Delayed Dissolution of a significant improvement in the stability of the soft capsule. Antipyretic analgesics powder soft capsule formulation of the active site quality standards and stability study results show that the quality of the preparation is controllable, and has good stability, in line with the relevant requirements of the development of preparations. This paper studies the results showed that the antipyretic analgesic bulk of the research and development of soft capsule preparation of the active site is feasible for lay a solid foundation based on the hospital preparations of the above research development or traditional Chinese medicine development of new drugs.

Study on the Soft Capsules of the Effective Fractions from "Antipyretic Analgesics Powder"

Abstract

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